Trial Outcomes & Findings for Evaluation of QDOT MICRO™ Catheter for Pulmonary Vein Isolation in Subjects With Paroxysmal Atrial Fibrillation (NCT NCT03775512)

Last Updated: 2023-03-16

Results Overview

An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. A Primary AEs is an event which occurred within 90 days following initial and repeated ablation procedure using the QDOT MICRO. Primary AEs included: atrio-esophageal fistula and pulmonary vein stenosis.

Recruitment status

COMPLETED

Study phase

Target enrollment

283 participants

Primary outcome timeframe

Up to 90 days (post initial and repeated ablation procedure)

Results posted on

2023-03-16

Participant Flow

Participant milestones

Participant milestones
Measure	Main Arm: QDOT Micro Catheter Participants with symptomatic paroxysmal atrial fibrillation (PAF) who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and radiofrequency (RF) ablation using QDOT Micro Catheter for pulmonary vein isolation with nMARQ radiofrequency (RF) generator.	Variable Flow Arm: QDOT Micro Catheter Participants with symptomatic PAF who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and RF ablation using QDOT Micro Catheter for variable flow with nMARQ RF generator.
Overall Study STARTED	191	92
Overall Study Treated	177	87
Overall Study COMPLETED	162	75
Overall Study NOT COMPLETED	29	17

Reasons for withdrawal

Reasons for withdrawal
Measure	Main Arm: QDOT Micro Catheter Participants with symptomatic paroxysmal atrial fibrillation (PAF) who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and radiofrequency (RF) ablation using QDOT Micro Catheter for pulmonary vein isolation with nMARQ radiofrequency (RF) generator.	Variable Flow Arm: QDOT Micro Catheter Participants with symptomatic PAF who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and RF ablation using QDOT Micro Catheter for variable flow with nMARQ RF generator.
Overall Study Death	1	1
Overall Study Withdrawal by Subject	7	4
Overall Study Lost to Follow-up	5	5
Overall Study Excluded before Catheter insertion	14	5
Overall Study Discontinued before RF energy applied on inserted catheter	2	1
Overall Study Due to a late entrance criteria deviation	0	1

Baseline Characteristics

Evaluation of QDOT MICRO™ Catheter for Pulmonary Vein Isolation in Subjects With Paroxysmal Atrial Fibrillation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Main Arm: QDOT Micro Catheter n=191 Participants Participants with symptomatic paroxysmal atrial fibrillation (PAF) who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and radiofrequency (RF) ablation using QDOT Micro Catheter for pulmonary vein isolation with nMARQ radiofrequency (RF) generator.	Variable Flow Arm: QDOT Micro Catheter n=92 Participants Participants with symptomatic PAF who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and RF ablation using QDOT Micro Catheter for variable flow with nMARQ RF generator.	Total n=283 Participants Total of all reporting groups
Age, Continuous	63.5 years STANDARD_DEVIATION 10.69 • n=5 Participants	64.5 years STANDARD_DEVIATION 9.75 • n=7 Participants	64.0 years STANDARD_DEVIATION 10.22 • n=5 Participants
Sex: Female, Male Female	75 Participants n=5 Participants	38 Participants n=7 Participants	113 Participants n=5 Participants
Sex: Female, Male Male	116 Participants n=5 Participants	54 Participants n=7 Participants	170 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants	4 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) White	166 Participants n=5 Participants	71 Participants n=7 Participants	237 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	17 Participants n=5 Participants	14 Participants n=7 Participants	31 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 90 days (post initial and repeated ablation procedure)

Population: The modified Intent-to-treat (mITT) analysis set included all enrolled participants who met all eligibility criteria and have the investigational device inserted.

Outcome measures

Outcome measures
Measure	Main Arm: QDOT Micro Catheter n=167 Participants Participants with symptomatic paroxysmal atrial fibrillation (PAF) who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and radiofrequency (RF) ablation using QDOT Micro Catheter for pulmonary vein isolation with nMARQ radiofrequency (RF) generator.	Variable Flow Arm: QDOT Micro Catheter n=85 Participants Participants with symptomatic PAF who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and RF ablation using QDOT Micro Catheter for variable flow with nMARQ RF generator.
Percentage of Participants With Early Onset Primary Adverse Events (PAEs): Atrio-esophageal Fistula and Pulmonary Vein (PV) Stenosis	0 Percentage of Participants	0 Percentage of Participants

PRIMARY outcome

Timeframe: Up to 7 days (post initial and repeated ablation procedure)

Population: The mITT analysis set included all enrolled participants who met all eligibility criteria and have the investigational device inserted.

A Primary AEs is an event which occurred within the first week (7 days of the initial and repeated ablation procedure) which included death, myocardial infraction (MI), cardiac tamponade (CT)/perforation, thromboembolism, stroke/cardiovascular accident (CVA), transient ischemic attack (TIA), phrenic nerve paralysis (PNP), heart block, pulmonary edema, vagal nerve injury, pericarditis, and major vascular access complication/bleeding (MVAC).

Outcome measures

Outcome measures
Measure	Main Arm: QDOT Micro Catheter n=167 Participants Participants with symptomatic paroxysmal atrial fibrillation (PAF) who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and radiofrequency (RF) ablation using QDOT Micro Catheter for pulmonary vein isolation with nMARQ radiofrequency (RF) generator.	Variable Flow Arm: QDOT Micro Catheter n=85 Participants Participants with symptomatic PAF who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and RF ablation using QDOT Micro Catheter for variable flow with nMARQ RF generator.
Percentage of Participants With Early Onset PAEs: Death, Myocardial Infraction, Cardiac Tamponade/Perforation, Thromboembolism, Stroke/Cardiovascular Accident , TIA, PNP, Heart Block, Pulmonary Edema, Vagal Nerve Injury, Pericarditis, and MVAC/Bleeding	3.6 Percentage of Participants	2.4 Percentage of Participants

PRIMARY outcome

Timeframe: Day 91 to Day 365

Population: The per-protocol (PP) analysis set included participants who satisfied the following criteria: a) enrolled and meet eligibility criteria, b) had undergone RF ablation, c) were treated with the study catheters, and d) were treated for the study related arrhythmia, without major protocol deviations that deemed to affect the scientific integrity of the study. Here 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure.

Percentage of participants with freedom from documented AF, AT, or AFL episodes or following failure modes: a) Acute procedural: Failure to confirm entrance block in all pulmonary veins post-procedure and use of a non-study catheter to treat left atrial ablation targets and Cavo-tricuspid isthmus; b) Repeat ablation: \>2 repeat ablation procedures with the study catheter during the 3-Month blanking period (Day 0-90) after the index ablation procedure, use of a non-study catheter to treat study arrhythmia ablation targets during the blanking period, and any repeat ablation procedure during the Evaluation Period; c) Antiarrhythmic drug: taking a new AAD for AF or a previously failed AAD at a greater than the highest ineffective historical dose for AF during the evaluation period, were reported.

Outcome measures

Outcome measures
Measure	Main Arm: QDOT Micro Catheter n=156 Participants Participants with symptomatic paroxysmal atrial fibrillation (PAF) who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and radiofrequency (RF) ablation using QDOT Micro Catheter for pulmonary vein isolation with nMARQ radiofrequency (RF) generator.	Variable Flow Arm: QDOT Micro Catheter n=77 Participants Participants with symptomatic PAF who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and RF ablation using QDOT Micro Catheter for variable flow with nMARQ RF generator.
Percentage of Participants With Freedom From Documented Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) Episodes or Other Failure Modes	76.3 Percentage of Participants	67.5 Percentage of Participants

SECONDARY outcome

Timeframe: Up to 20 months

Population: The safety analysis set included all enrolled participants of the study who had the investigational device inserted, regardless if RF energy was delivered.

Number of participants with UADEs were reported.

Outcome measures

Outcome measures
Measure	Main Arm: QDOT Micro Catheter n=177 Participants Participants with symptomatic paroxysmal atrial fibrillation (PAF) who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and radiofrequency (RF) ablation using QDOT Micro Catheter for pulmonary vein isolation with nMARQ radiofrequency (RF) generator.	Variable Flow Arm: QDOT Micro Catheter n=87 Participants Participants with symptomatic PAF who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and RF ablation using QDOT Micro Catheter for variable flow with nMARQ RF generator.
Number of Participants With Unanticipated Adverse Device Effects (UADEs)	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Within 7 days (early onset), 8-30 days (peri-procedural) and >=31 days (late onset) of initial ablation procedure (up to 20 months)

Population: The safety analysis set included all enrolled participants of the study who had the investigational device inserted, regardless if RF energy was delivered.

Number of participants with serious non-primary AEs within 7 days (early onset), 8-30 days (peri-procedural) and \>=31 days (late onset) of initial ablation were reported.

Outcome measures

Outcome measures
Measure	Main Arm: QDOT Micro Catheter n=177 Participants Participants with symptomatic paroxysmal atrial fibrillation (PAF) who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and radiofrequency (RF) ablation using QDOT Micro Catheter for pulmonary vein isolation with nMARQ radiofrequency (RF) generator.	Variable Flow Arm: QDOT Micro Catheter n=87 Participants Participants with symptomatic PAF who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and RF ablation using QDOT Micro Catheter for variable flow with nMARQ RF generator.
Number of Participants With Serious Non-Primary Adverse Events (SAEs) Within 7 Days (Early Onset), 8-30 Days (Peri-procedural) and Greater Than or Equal to (>=) 31 Days (Late Onset) of Initial Ablation Procedure 0 - 7 Days	8 Participants	4 Participants
Number of Participants With Serious Non-Primary Adverse Events (SAEs) Within 7 Days (Early Onset), 8-30 Days (Peri-procedural) and Greater Than or Equal to (>=) 31 Days (Late Onset) of Initial Ablation Procedure 8 - 30 Days	4 Participants	3 Participants
Number of Participants With Serious Non-Primary Adverse Events (SAEs) Within 7 Days (Early Onset), 8-30 Days (Peri-procedural) and Greater Than or Equal to (>=) 31 Days (Late Onset) of Initial Ablation Procedure >= 31 Days	25 Participants	12 Participants

SECONDARY outcome

Timeframe: Within 7 days (early onset), 8-30 days (peri-procedural) and >=31 days (late onset) of initial ablation procedure (up to 20 months)

Population: The safety analysis set included all enrolled participants of the study who had the investigational device inserted, regardless if RF energy was delivered.

Number of participants with bleeding complication (ISTH definitions): a) major, b) clinically relevant non-major and c) minor bleeding were reported. The ISTH classification of major bleeding event is a hemoglobin drop of greater than or equal to (\>=) 2 grams per deciliter (g/dL), transfusion of \>= 2 units (U) packed red blood cells, symptomatic bleed in a critical area, or fatal bleed. Clinically relevant non-major (CRNM) events require prolong hospitalization or result in laboratory testing, imaging, compression, procedure, interruption of the study medication or a change in concomitant therapy. Minor bleeding events are overt bleeding events that do not meet the criteria for CRNM or major bleeding events.

Outcome measures

Outcome measures
Measure	Main Arm: QDOT Micro Catheter n=177 Participants Participants with symptomatic paroxysmal atrial fibrillation (PAF) who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and radiofrequency (RF) ablation using QDOT Micro Catheter for pulmonary vein isolation with nMARQ radiofrequency (RF) generator.	Variable Flow Arm: QDOT Micro Catheter n=87 Participants Participants with symptomatic PAF who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and RF ablation using QDOT Micro Catheter for variable flow with nMARQ RF generator.
Number of Participants With Bleeding Complication by International Society on Thrombosis and Haemostasis (ISTH) Class and Timing of Onset Major: 0 - 7 Days	3 Participants	0 Participants
Number of Participants With Bleeding Complication by International Society on Thrombosis and Haemostasis (ISTH) Class and Timing of Onset Major: 8 - 30 Days	0 Participants	0 Participants
Number of Participants With Bleeding Complication by International Society on Thrombosis and Haemostasis (ISTH) Class and Timing of Onset Major: >= 31 Days	0 Participants	0 Participants
Number of Participants With Bleeding Complication by International Society on Thrombosis and Haemostasis (ISTH) Class and Timing of Onset CRNM: 0-7 Days	3 Participants	0 Participants
Number of Participants With Bleeding Complication by International Society on Thrombosis and Haemostasis (ISTH) Class and Timing of Onset CRNM: 8-30 Days	0 Participants	0 Participants
Number of Participants With Bleeding Complication by International Society on Thrombosis and Haemostasis (ISTH) Class and Timing of Onset CRNM: >= 31 Days	2 Participants	0 Participants
Number of Participants With Bleeding Complication by International Society on Thrombosis and Haemostasis (ISTH) Class and Timing of Onset Minor: 0-7 Days	5 Participants	0 Participants
Number of Participants With Bleeding Complication by International Society on Thrombosis and Haemostasis (ISTH) Class and Timing of Onset Minor: 8-30 Days	1 Participants	0 Participants
Number of Participants With Bleeding Complication by International Society on Thrombosis and Haemostasis (ISTH) Class and Timing of Onset Minor: >= 31 Days	2 Participants	0 Participants

SECONDARY outcome

Timeframe: End of the Procedure (up to 20 months)

Population: The PP analysis set included participants who satisfied the following criteria: a) enrolled and meet eligibility criteria, b) had undergone RF ablation, c) were treated with the study catheters, and d) were treated for the study related arrhythmia, without major protocol deviations that deemed to affect the scientific integrity of the study. Here 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure.

Percentage of participants with electrical isolation of PVs (entrance block) at the end of the procedure were reported

Outcome measures

Outcome measures
Measure	Main Arm: QDOT Micro Catheter n=164 Participants Participants with symptomatic paroxysmal atrial fibrillation (PAF) who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and radiofrequency (RF) ablation using QDOT Micro Catheter for pulmonary vein isolation with nMARQ radiofrequency (RF) generator.	Variable Flow Arm: QDOT Micro Catheter n=82 Participants Participants with symptomatic PAF who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and RF ablation using QDOT Micro Catheter for variable flow with nMARQ RF generator.
Percentage of Participants With Electrical Isolation of Pulmonary Veins (PVs) (Entrance Block) at the End of the Procedure	100 Percentage of Participants	100 Percentage of Participants

SECONDARY outcome

Timeframe: Up to 20 months

Percentage of participants with electrical isolation of PV after first encirclement with acute reconnection were reported.

Outcome measures

Outcome measures
Measure	Main Arm: QDOT Micro Catheter n=164 Participants Participants with symptomatic paroxysmal atrial fibrillation (PAF) who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and radiofrequency (RF) ablation using QDOT Micro Catheter for pulmonary vein isolation with nMARQ radiofrequency (RF) generator.	Variable Flow Arm: QDOT Micro Catheter n=82 Participants Participants with symptomatic PAF who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and RF ablation using QDOT Micro Catheter for variable flow with nMARQ RF generator.
Percentage of Participants With Electrical Isolation of PV After First Encirclement With Acute Reconnection	42.7 Percentage of Participants	31.7 Percentage of Participants

SECONDARY outcome

Timeframe: Up to 20 months

Percentage of participants with electrical isolation of PV after first encirclement without acute reconnection were reported.

Outcome measures

Outcome measures
Measure	Main Arm: QDOT Micro Catheter n=164 Participants Participants with symptomatic paroxysmal atrial fibrillation (PAF) who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and radiofrequency (RF) ablation using QDOT Micro Catheter for pulmonary vein isolation with nMARQ radiofrequency (RF) generator.	Variable Flow Arm: QDOT Micro Catheter n=82 Participants Participants with symptomatic PAF who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and RF ablation using QDOT Micro Catheter for variable flow with nMARQ RF generator.
Percentage of Participants With Electrical Isolation of PV After First Encirclement Without Acute Reconnection	57.3 Percentage of Participants	68.3 Percentage of Participants

SECONDARY outcome

Timeframe: Up to 20 months

Percentage of participants with PV touch-up were reported. PV touch-up was defined as additional ablations being performed after first encirclement for targeted veins with acute reconnection.

Outcome measures

Outcome measures
Measure	Main Arm: QDOT Micro Catheter n=164 Participants Participants with symptomatic paroxysmal atrial fibrillation (PAF) who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and radiofrequency (RF) ablation using QDOT Micro Catheter for pulmonary vein isolation with nMARQ radiofrequency (RF) generator.	Variable Flow Arm: QDOT Micro Catheter n=82 Participants Participants with symptomatic PAF who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and RF ablation using QDOT Micro Catheter for variable flow with nMARQ RF generator.
Percentage of Participants With Pulmonary Veins (PV) Touch-up	42.7 Percentage of Participants	31.7 Percentage of Participants

SECONDARY outcome

Timeframe: Up to 20 months

Percentage of targeted veins with touch-up (ablation of acute reconnection) among all targeted veins were reported.

Outcome measures

Outcome measures
Measure	Main Arm: QDOT Micro Catheter n=328 Targeted Veins Participants with symptomatic paroxysmal atrial fibrillation (PAF) who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and radiofrequency (RF) ablation using QDOT Micro Catheter for pulmonary vein isolation with nMARQ radiofrequency (RF) generator.	Variable Flow Arm: QDOT Micro Catheter n=164 Targeted Veins Participants with symptomatic PAF who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and RF ablation using QDOT Micro Catheter for variable flow with nMARQ RF generator.
Percentage of Targeted Veins With Touch-up (Ablation of Acute Reconnection) Among All Targeted Veins	27.4 Percentage of Targeted Veins	20.7 Percentage of Targeted Veins

SECONDARY outcome

Timeframe: Up to 20 months

Population: The PP set had participants who satisfied these criteria: a) enrolled and meet eligibility criteria, b) had undergone RF ablation, c) treated with the study catheters, and d) were treated for the study related arrhythmia, without major protocol deviations that deemed to affect the scientific integrity of the study. Here 'N' (number of participants analyzed) is number of participants analyzed for this endpoint and 'n' (number analyzed) is number of participants analyzed for specified categories.

Percentage of participants with touch-up at anatomical location of acute PV reconnection after first encirclement was reported. The location included anterior, superior, ridge, posterior, and inferior region of the left pulmonary veins (LPV) and right pulmonary veins (RPV). The review of all ablation targets for the 1 participant with RPV ridge entered by site resulted in reclassification to RPV superior. This outcome measure was planned to be analyzed for specified arm (main arm) only.

Outcome measures

Outcome measures
Measure	Main Arm: QDOT Micro Catheter n=45 Participants Participants with symptomatic paroxysmal atrial fibrillation (PAF) who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and radiofrequency (RF) ablation using QDOT Micro Catheter for pulmonary vein isolation with nMARQ radiofrequency (RF) generator.	Variable Flow Arm: QDOT Micro Catheter Participants with symptomatic PAF who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and RF ablation using QDOT Micro Catheter for variable flow with nMARQ RF generator.
Percentage of Participants With Touch-up at Anatomical Location of Acute PV Reconnection After First Encirclement LPV: Anterior	31.1 Percentage of Participants	—
Percentage of Participants With Touch-up at Anatomical Location of Acute PV Reconnection After First Encirclement LPV: Inferior	28.9 Percentage of Participants	—
Percentage of Participants With Touch-up at Anatomical Location of Acute PV Reconnection After First Encirclement LPV: Posterior	53.3 Percentage of Participants	—
Percentage of Participants With Touch-up at Anatomical Location of Acute PV Reconnection After First Encirclement LPV: Ridge	42.2 Percentage of Participants	—
Percentage of Participants With Touch-up at Anatomical Location of Acute PV Reconnection After First Encirclement LPV: Superior	44.4 Percentage of Participants	—
Percentage of Participants With Touch-up at Anatomical Location of Acute PV Reconnection After First Encirclement RPV: Anterior	53.5 Percentage of Participants	—
Percentage of Participants With Touch-up at Anatomical Location of Acute PV Reconnection After First Encirclement RPV: Inferior	37.2 Percentage of Participants	—
Percentage of Participants With Touch-up at Anatomical Location of Acute PV Reconnection After First Encirclement RPV: Posterior	58.1 Percentage of Participants	—
Percentage of Participants With Touch-up at Anatomical Location of Acute PV Reconnection After First Encirclement RPV: Superior	27.9 Percentage of Participants	—

SECONDARY outcome

Timeframe: Up to 20 months

Percentage of participants who underwent repeat ablation procedures were reported.

Outcome measures

Outcome measures
Measure	Main Arm: QDOT Micro Catheter n=166 Participants Participants with symptomatic paroxysmal atrial fibrillation (PAF) who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and radiofrequency (RF) ablation using QDOT Micro Catheter for pulmonary vein isolation with nMARQ radiofrequency (RF) generator.	Variable Flow Arm: QDOT Micro Catheter n=82 Participants Participants with symptomatic PAF who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and RF ablation using QDOT Micro Catheter for variable flow with nMARQ RF generator.
Percentage of Participants Who Underwent Repeat Ablation Procedures	10.8 Percentage of Participants	13.4 Percentage of Participants

SECONDARY outcome

Timeframe: Up to 20 months

Percentage of participants with PVs re-isolation among all of the targeted PVs at repeat procedure were reported.

Outcome measures

Outcome measures
Measure	Main Arm: QDOT Micro Catheter n=23 Participants Participants with symptomatic paroxysmal atrial fibrillation (PAF) who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and radiofrequency (RF) ablation using QDOT Micro Catheter for pulmonary vein isolation with nMARQ radiofrequency (RF) generator.	Variable Flow Arm: QDOT Micro Catheter n=11 Participants Participants with symptomatic PAF who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and RF ablation using QDOT Micro Catheter for variable flow with nMARQ RF generator.
Percentage of Participants With PVs Re-isolation Among All of the Targeted PVs at Repeat Procedure	100 Percentage of Participants	100 Percentage of Participants

SECONDARY outcome

Timeframe: Up to 20 months

Percentage of participants requiring new linear lesion and/or new foci identified during the repeat ablation procedure were reported.

Outcome measures

Outcome measures
Measure	Main Arm: QDOT Micro Catheter n=18 Participants Participants with symptomatic paroxysmal atrial fibrillation (PAF) who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and radiofrequency (RF) ablation using QDOT Micro Catheter for pulmonary vein isolation with nMARQ radiofrequency (RF) generator.	Variable Flow Arm: QDOT Micro Catheter n=11 Participants Participants with symptomatic PAF who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and RF ablation using QDOT Micro Catheter for variable flow with nMARQ RF generator.
Percentage of Participants Requiring New Linear Lesion and/or New Foci Identified During the Repeat Ablation Procedure	50.0 Percentage of Participants	63.6 Percentage of Participants

SECONDARY outcome

Timeframe: Up to 12 months

Percentage of participants with 12-month single procedure success were reported. The 12-month single procedure success is defined as freedom from documented AF/AFL/AT recurrence (episodes \> 30 seconds) during the evaluation period after a single ablation procedure.

Outcome measures

Outcome measures
Measure	Main Arm: QDOT Micro Catheter n=166 Participants Participants with symptomatic paroxysmal atrial fibrillation (PAF) who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and radiofrequency (RF) ablation using QDOT Micro Catheter for pulmonary vein isolation with nMARQ radiofrequency (RF) generator.	Variable Flow Arm: QDOT Micro Catheter n=82 Participants Participants with symptomatic PAF who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and RF ablation using QDOT Micro Catheter for variable flow with nMARQ RF generator.
Percentage of Participants With 12-Month Single Procedure Success	77.3 Percentage of Participants	72.4 Percentage of Participants

Adverse Events

Main Arm: QDOT Micro Catheter

Serious events: 32 serious events

Other events: 58 other events

Deaths: 1 deaths

Variable Flow Arm: QDOT Micro Catheter

Serious events: 14 serious events

Other events: 19 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Additional Information

Franchise Medical Manager

Biosense Webster, Inc.

Phone: 844-434-4210

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Publications and presentation of clinical investigation results will be coordinated between sponsor and the clinical investigation authors. Authorship to be determined prior to development of any manuscript. All information concerning the study, investigational medical device, sponsor operations, patent application, manufacturing processes and basic scientific data supplied by the sponsor to the investigator and not previously published, are confidential and remain sole property of the sponsor.
Publication restrictions are in place

Restriction type: OTHER

Measure	Main Arm: QDOT Micro Catheter n=177 participants at risk Participants with symptomatic paroxysmal atrial fibrillation (PAF) who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and radiofrequency (RF) ablation using QDOT Micro Catheter for pulmonary vein isolation with nMARQ radiofrequency (RF) generator.	Variable Flow Arm: QDOT Micro Catheter n=87 participants at risk Participants with symptomatic PAF who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and RF ablation using QDOT Micro Catheter for variable flow with nMARQ RF generator.
Cardiac disorders Atrial fibrillation	7.9% 14/177 • Number of events 16 • Up to 20 months The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.	6.9% 6/87 • Number of events 6 • Up to 20 months The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.
Cardiac disorders Atrial flutter	4.5% 8/177 • Number of events 8 • Up to 20 months The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.	4.6% 4/87 • Number of events 4 • Up to 20 months The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.
Cardiac disorders Cardiac failure congestive	1.1% 2/177 • Number of events 2 • Up to 20 months The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.	2.3% 2/87 • Number of events 2 • Up to 20 months The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.
Cardiac disorders Cardiac tamponade	1.1% 2/177 • Number of events 2 • Up to 20 months The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.	0.00% 0/87 • Up to 20 months The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.
General disorders Chest pain	3.4% 6/177 • Number of events 6 • Up to 20 months The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.	0.00% 0/87 • Up to 20 months The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.
General disorders Pyrexia	1.1% 2/177 • Number of events 2 • Up to 20 months The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.	0.00% 0/87 • Up to 20 months The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.
Vascular disorders Arteriovenous fistula	1.1% 2/177 • Number of events 2 • Up to 20 months The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.	0.00% 0/87 • Up to 20 months The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.00% 0/177 • Up to 20 months The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.	2.3% 2/87 • Number of events 2 • Up to 20 months The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.
Cardiac disorders Sinus node dysfunction	0.00% 0/177 • Up to 20 months The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.	2.3% 2/87 • Number of events 2 • Up to 20 months The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cardiac valve fibroelastoma	0.00% 0/177 • Up to 20 months The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.	2.3% 2/87 • Number of events 2 • Up to 20 months The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.
Nervous system disorders Headache	0.56% 1/177 • Number of events 1 • Up to 20 months The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.	4.6% 4/87 • Number of events 4 • Up to 20 months The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.
Nervous system disorders Migraine	0.00% 0/177 • Up to 20 months The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.	3.4% 3/87 • Number of events 3 • Up to 20 months The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.
Cardiac disorders Pericardial effusion	1.1% 2/177 • Number of events 2 • Up to 20 months The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.	0.00% 0/87 • Up to 20 months The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	1.1% 2/177 • Number of events 2 • Up to 20 months The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.	0.00% 0/87 • Up to 20 months The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.
Cardiac disorders Cardiac failure	0.00% 0/177 • Up to 20 months The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.	2.3% 2/87 • Number of events 2 • Up to 20 months The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.
Blood and lymphatic system disorders Thrombocytopenia	1.1% 2/177 • Number of events 2 • Up to 20 months The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.	0.00% 0/87 • Up to 20 months The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.
Cardiac disorders Angina unstable	1.1% 2/177 • Number of events 2 • Up to 20 months The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.	2.3% 2/87 • Number of events 2 • Up to 20 months The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.
Cardiac disorders Atrial tachycardia	1.1% 2/177 • Number of events 2 • Up to 20 months The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.	4.6% 4/87 • Number of events 4 • Up to 20 months The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.
Cardiac disorders Atrioventricular block	1.1% 2/177 • Number of events 2 • Up to 20 months The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.	0.00% 0/87 • Up to 20 months The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.
Cardiac disorders Cardiac arrest	1.1% 2/177 • Number of events 2 • Up to 20 months The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.	0.00% 0/87 • Up to 20 months The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.
Cardiac disorders Tachycardia	2.3% 4/177 • Number of events 4 • Up to 20 months The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.	0.00% 0/87 • Up to 20 months The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.
Cardiac disorders Ventricular extrasystoles	1.1% 2/177 • Number of events 2 • Up to 20 months The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.	0.00% 0/87 • Up to 20 months The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.
General disorders Cyst	1.1% 2/177 • Number of events 2 • Up to 20 months The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.	0.00% 0/87 • Up to 20 months The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	1.1% 2/177 • Number of events 2 • Up to 20 months The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.	0.00% 0/87 • Up to 20 months The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.
Nervous system disorders Syncope	0.56% 1/177 • Number of events 1 • Up to 20 months The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.	0.00% 0/87 • Up to 20 months The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.
Nervous system disorders Transient ischemic attack	0.56% 1/177 • Number of events 1 • Up to 20 months The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.	0.00% 0/87 • Up to 20 months The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.1% 2/177 • Number of events 2 • Up to 20 months The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.	0.00% 0/87 • Up to 20 months The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.
Vascular disorders Aortic dilatation	1.1% 2/177 • Number of events 2 • Up to 20 months The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.	0.00% 0/87 • Up to 20 months The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.
Vascular disorders Orthostatic hypotension	1.1% 2/177 • Number of events 2 • Up to 20 months The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.	0.00% 0/87 • Up to 20 months The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.
Gastrointestinal disorders Abdominal pain	1.1% 2/177 • Number of events 2 • Up to 20 months The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.	0.00% 0/87 • Up to 20 months The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.
Gastrointestinal disorders Gastrointestinal hemorrhage	1.1% 2/177 • Number of events 2 • Up to 20 months The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.	0.00% 0/87 • Up to 20 months The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.
Gastrointestinal disorders Hiatus hernia	1.1% 2/177 • Number of events 2 • Up to 20 months The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.	0.00% 0/87 • Up to 20 months The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.
Infections and infestations Abscess	1.1% 2/177 • Number of events 2 • Up to 20 months The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.	0.00% 0/87 • Up to 20 months The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.
Infections and infestations Diverticulitis	1.1% 2/177 • Number of events 2 • Up to 20 months The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.	0.00% 0/87 • Up to 20 months The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.
Infections and infestations Pneumonia	2.3% 4/177 • Number of events 4 • Up to 20 months The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.	0.00% 0/87 • Up to 20 months The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.
Injury, poisoning and procedural complications Vascular pseudoaneurysm	1.1% 2/177 • Number of events 2 • Up to 20 months The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.	0.00% 0/87 • Up to 20 months The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.
Musculoskeletal and connective tissue disorders Arthropathy	1.1% 2/177 • Number of events 2 • Up to 20 months The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.	0.00% 0/87 • Up to 20 months The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.
Musculoskeletal and connective tissue disorders Bursitis	1.1% 2/177 • Number of events 2 • Up to 20 months The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.	0.00% 0/87 • Up to 20 months The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.
Renal and urinary disorders Nephrolithiasis	1.1% 2/177 • Number of events 2 • Up to 20 months The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.	0.00% 0/87 • Up to 20 months The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.
Cardiac disorders Aortic valve calcification	0.00% 0/177 • Up to 20 months The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.	2.3% 2/87 • Number of events 2 • Up to 20 months The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.
Cardiac disorders Cardiovascular disorder	0.00% 0/177 • Up to 20 months The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.	2.3% 2/87 • Number of events 2 • Up to 20 months The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.
Gastrointestinal disorders Retroperitoneal haemorrhage	0.00% 0/177 • Up to 20 months The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.	2.3% 2/87 • Number of events 2 • Up to 20 months The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.
General disorders Chest discomfort	0.00% 0/177 • Up to 20 months The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.	2.3% 2/87 • Number of events 2 • Up to 20 months The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.
Infections and infestations Corona virus infection	0.00% 0/177 • Up to 20 months The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.	2.3% 2/87 • Number of events 2 • Up to 20 months The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.
Injury, poisoning and procedural complications Hip fracture	0.00% 0/177 • Up to 20 months The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.	2.3% 2/87 • Number of events 2 • Up to 20 months The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.
Nervous system disorders Haemorrhagic stroke	0.00% 0/177 • Up to 20 months The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.	2.3% 2/87 • Number of events 2 • Up to 20 months The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.
Vascular disorders Peripheral vascular disorder	0.00% 0/177 • Up to 20 months The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.	2.3% 2/87 • Number of events 2 • Up to 20 months The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.